MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number KORA 250 DR

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by (b)(4) that was cleared or approved by fda for marketing in the united states.

Event Description

Connection issues were reported relative to the subject pacemaker.Reportedly while inserting the lead into the ventricular port of the device, the set-screw was attempted to be tightened.However no click sound was heard neither tightening of the set-crew was felt by the physician where as the screwdriver was rotated multiple times.Another physician tried to tighten the ventricular set-screw unsuccessfully.After the ventricular lead was disconnected from the ventricular port, the ventricular set-screw was rotated with no lead inserted into the port.Then, a click sound was heard along with rotation of the set-screw with the screwdriver.Another pacemaker was implanted.

Event Description

Connection issues were reported relative to the subject pacemaker.Reportedly while inserting the lead into the ventricular port of the device, the set-screw was attempted to be tightened.However no click sound was heard neither tightening of the set-crew was felt by the physician whereas the screwdriver was rotated multiple times.Another physician tried to tighten the ventricular set-screw unsuccessfully.After the ventricular lead was disconnected from the ventricular port, the ventricular set-screw was rotated with no lead inserted into the port.Then, a click sound was heard along with rotation of the set-screw with the screwdriver.Another pacemaker was implanted.

• Brand Name: KORA
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 6456041
• MDR Text Key: 71896770
• Report Number: 1000165971-2017-00277
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/27/2018
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Device Lot Number: S0203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/28/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1